BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 6909630 · Received October 3, 2017

    Report

    Report Number
    2936999-2017-05510
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    August 31, 2017
    Report Date
    October 31, 2017
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    DQA
    UDI-DI
    20884521208787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE ASSOCIATED TO THIS REPORT WAS RECEIVED AND THE CUSTOMER REPORTED ISSUE COULD NOT BE DUPLICATED.  WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT HOWEVER, MANUFACTURING CONTROLS ARE IN PLACE TO DETECT DAMAGE AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNIT WAS PROVIDING LOW (SP02) READINGS BY COMPARISON WITH THE SAME MONITOR TO ANOTHER SENSOR. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690158 NELLCOR OXIMETER DQA MEDIANA CO. LTD. PM10N 20884521208787

    Patients

    Seq Age Sex Outcome Treatment
    1